Irbesartan and Hydrochlorothiazide
- Product NDC
- 43547-331
- 11-digit product format
- 435470331
- Labeler code
- 43547
- Product ID
- 43547-331_3e6f512c-8ff3-40b0-bcd3-9bf9bf26a112
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA203072
- Marketing category
- ANDA
- Marketing start
- 2014-03-01
- Substance
- HYDROCHLOROTHIAZIDE; IRBESARTAN
- Active strength
- 12.5; 300 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| IRBESARTAN | 300 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0J48LPH2TH, J0E2756Z7N |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-331-03 | Irbesartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | 11 | |
| 43547-331-09 | Irbesartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | 11 | |
| 43547-331-50 | Irbesartan and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET | 500 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-331-03 | EA - Each | 43547-331 | 5504fb4c-48d6-49f9-8878-3b3852669afb | 1 | 2014-06-03 |
| 43547-331-09 | EA - Each | 43547-331 | d712cff5-1a8c-41f6-9674-399cd49a8e09 | 1 | 2014-06-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310793 | irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 88aaa2a1-13be-4f56-ace6-66e899028007 | 12 |
| 310793 | hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral Tablet | SCD | 88aaa2a1-13be-4f56-ace6-66e899028007 | 12 |
| 310793 | HCTZ 12.5 MG / irbesartan 300 MG Oral Tablet | SY | 88aaa2a1-13be-4f56-ace6-66e899028007 | 12 |
| 310792 | irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 72fa8cd4-bc2a-4a7d-8feb-2d60e077d801 | 11 |
| 310793 | irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 72fa8cd4-bc2a-4a7d-8feb-2d60e077d801 | 11 |
| 310792 | hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet | SCD | 72fa8cd4-bc2a-4a7d-8feb-2d60e077d801 | 11 |
| 310793 | hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral Tablet | SCD | 72fa8cd4-bc2a-4a7d-8feb-2d60e077d801 | 11 |
| 310792 | HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet | SY | 72fa8cd4-bc2a-4a7d-8feb-2d60e077d801 | 11 |
| 310793 | HCTZ 12.5 MG / irbesartan 300 MG Oral Tablet | SY | 72fa8cd4-bc2a-4a7d-8feb-2d60e077d801 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43547-331-03 | 43547033103 | 30 TABLET in 1 BOTTLE (43547-331-03) | 30 tablet | 2014-03-01 | 0000-00-00 | No | No | Current |
| 43547-331-09 | 43547033109 | 90 TABLET in 1 BOTTLE (43547-331-09) | 90 tablet | 2014-03-01 | 0000-00-00 | No | No | Current |
| 43547-331-50 | 43547033150 | 500 TABLET in 1 BOTTLE (43547-331-50) | 500 tablet | 2014-03-01 | 0000-00-00 | No | No | Current |